If you want bespoke regulatory solutions for your unique challenges
Our Services
“We help pharmaceutical companies maximise their business opportunities by creating bespoke regulatory solutions quicker than traditional regulatory affairs support”.
REGULATORY AFFAIRS
Hassle-free outsourcing
- Want to outsource your existing portfolio hassle-free? Say goodbye to endless agreements. Sometimes you have your internal process so complicated that you carry on working with you existing substandard service provider rather than going for A players in the field. We make it super easy by sharing our templates or working with your already agreed-upon ones, with just a few tweaks where applicable. Let’s keep it simple and efficient!
- Lacking communication, or worse, being ghosted by your service provider as if you’re no longer important. It’s like being stranded on a deserted island without a lifeline. With us, you’ll experience effective and consistent communication. We value our partnership and will never leave you hanging.
- Even after working together for a while, they still don’t understand your portfolio or your company. It’s like being stuck in a never-ending loop of explaining the same thing over and over again. We take the time to fully comprehend your portfolio and your company’s unique needs. No more repeating yourself or feeling misunderstood.
Take the burden off your shoulders so you can focus on other growth opportunities!
- Have you ever outsourced your regulatory affairs matters only to find yourself doing most of the work? It’s like paying someone to wash your car, but you end up scrubbing it yourself. Not cool. With us, you can sit back, relax, and let our experts handle the heavy lifting. No more wasted efforts on your end.
- Received work filled with silly mistakes, and it seems like there was zero quality control on their end. It’s like finding a pile of misspelled words in a published novel. We take quality seriously and ensure rigorous quality control processes are in place, sparing you the frustration of correcting someone else’s mistakes.
- Instead of freeing up your internal resources, you end up getting tangled in the project, neglecting your growth priorities. It’s like trying to juggle flaming torches while riding a unicycle. We’re here to take the burden off your shoulders so you can focus on what truly matters to your company’s growth.
Unlock limitless opportunities with our regulatory expertise
- Fed up with training your regulatory affairs service provider on regulatory expertise? It’s like hiring a chef to cook for you, but you end up teaching them how to boil water. With us, you’ll have a team of seasoned professionals who bring their expertise to the table. No more role reversal.
- Working with experts directly is one thing, but dealing with layers of intermediaries can dilute your message and slow down progress. It’s like playing a game of telephone with important information. With us, you’ll have direct access to our experts, ensuring clear and effective communication without any unnecessary middlemen.
- Not up to date with the latest regulatory knowledge and practices? It’s like using a typewriter in the age of artificial intelligence. We make it a priority to stay abreast of current regulations, ensuring that your projects are always in compliance and ahead of the curve.
Committed to delivering excellence
- Ever been in a situation where the RA service provider suddenly vanishes after securing your business? Don’t you just love chasing ghosts? Well, with us, that won’t happen. We’re here for the long haul, committed to delivering top-notch service even after the ink has dried on the agreement.
- Tired of explaining the same situation to multiple people from your outsourced supplier? It’s like playing a never-ending game of Chinese whispers. But fear not, with us, you’ll have a dedicated contact who actually listens and understands. No more repeating yourself to a crowd of confused voices.
- Frustrated with substandard quality of service? It’s like buying a cheap knockoff instead of the real deal. We pride ourselves on delivering nothing short of excellence. No more settling for less.
- Have you ever experienced the disappointment of a promised approval turning into a rejection? It’s like expecting a golden ticket to Willy Wonka’s Chocolate Factory, only to be told it’s invalid. We don’t just make promises; we deliver results. No more false hope or shattered dreams.
Stay in the know: gain complete visibility
- Ever felt left in the dark without regular progress reports on your products? It’s like being on a blindfolded rollercoaster ride. We believe in keeping you informed every step of the way, ensuring you have full visibility into the progress of your projects. No more surprises or guessing games.
- Wish you had a dedicated team solely focused on your products? It’s like having a personal army fighting for your success. Well, with us, you’ll have just that. A team dedicated to your specific needs, providing you with undivided attention.
- Instead of them chasing you, you end up chasing them for updates and progress. It’s like being in a never-ending game of cat and mouse. Well, with us, the tables are turned. We take the initiative and keep you in the loop, so you can focus on what’s important to you.
Time is of the essence: meet your deadlines with confidence
- Promised a specific timeline, but the project seems to have gone on an extended vacation? It’s like planning a party for Saturday night, only to find out it’s happening next year. We take timelines seriously and deliver on our promises. No more waiting endlessly for results.
- Ever had your RA service provider completely disregard both authority timelines and your own internal deadlines? It’s like watching a speeding train crash into a wall. We respect timelines, both from the authorities and within your organisation. No more delays or missed targets.
- Tired of waiting for responses, constantly playing the waiting game? It’s like watching paint dry in slow motion. We value your time and make it our mission to be responsive and proactive, so you can move forward with your projects without unnecessary delays.
Experience the value of your investment like never before
- Ever spent a fortune on services only to be left unsatisfied with the outcomes? It’s like buying a diamond and receiving a plastic trinket. We understand the value of your investment, and we strive to deliver services that not only meet but exceed your expectations. No more wasted funds.
- Ever agreed on a cost at the start of the project, only to see it change repeatedly and end up paying a fortune without even finishing the project? It’s like buying a cup of coffee and finding out it’s the price of a luxury yacht. We believe in transparency and sticking to agreed-upon costs. No surprises or inflated bills.
- Unlock cost-effective solutions without compromising on quality. Our efficient processes and expertise allow us to maximise the value of your investment, delivering outstanding results within your budget.
- Gain a competitive edge in the market while optimising your resources.
Choose a regulatory affairs service which takes your regulatory worries away and delivers a top-notch experience.
Regulatory Strategies
Out-of-the-box Global Regulatory Strategies which give competitive advantage and confidence to regulators and your customers about the quality, efficacy and safety of your product. Global RA strategy to cover all the markets identified in the commercial plan with minimum possible costing and timelines.
CMC Services
CMC strategy and documentation plays an important role from
early development to the authoring of the marketing authorisation application dossier as best healthcare consulting firms. It also extends to change control and maintenance throughout the product lifecycle. Assure Regulatory guides you to the best CMC approach for your products in line with health authority requirements and
helps you to stay CMC compliant with sustainable processes.
Global End-to-End Outsourcing
You will find the true meaning of outsourcing with Assure Regulatory. We take pressure off from your internal resources and give you regular reports about the progress of your projects.
Global Procedure Management
The economic success of pharmaceutical companies
heavily depends on their ability
to take the right decisions regarding their marketing
strategy and how they transform their vision into efficient operations.
During the development cycle, there are many interfaces that require proactive planning and management. Assure Regulatory offers a holistic approach to Global Procedure Management, ensuring an end-in-mind process with seamless integration of all necessary aspects and steps of the development with minimum possible costing and timelines.
Health Authority / Agency Interaction
Picking things upfront is very important when it comes to Health Agency Interaction. What does this mean? It means approaching an agency with full preparation rather than submitting a sub-optimal
package or information which takes longer to get approval and dent your reputation with agencies.
Marketing & Labeling Activities
A simple change to marketing
and labeling activities/materials can give away your whole marketing advantage. So Assure Regulatory will provide you with the advice to get and maintain your competitive advantage by handling your marketing and labeling activities which are in
line with regulatory expectations and delivering patient safety but put you in control.
Scientific, Regulatory & Technical Writing
How to present the information
is key in Scientific, Regulatory
and Technical Writing. If this is
not done properly then even though you have good information and data but the agency would not be convinced. Assure Regulatory are experts
as best healthcare consulting firms in presenting your good information/data in a better way.
Mergers & Acquisitions (M&A) Transfers
Transition periods are very
tricky as if not done properly
then it take longer to implement your company culture and maintain the synergies which grow the business rather than bring hurdles in business growth. Assure Regulatory smooth handling of the whole process
will give you the results for
which you merge or acquire
the new business.
In this short but powerful session, We will
- Rapid Assessment: Get to know you, your business, and the background of the current biggest regulatory challenge you are facing.
- Crystal-Clear vision: Get a crystal-clear vision of what outcome you are looking for, and identify obvious and completely not obvious regulatory traps in the way of your outcome.
- Customised Strategies: Create bespoke regulatory solutions for your biggest regulatory challenge at the moment.
- Q&A Session: Get answers to your burning questions and gain clarity on regulatory challenges that have been holding you back.
Book a time that works best for you and make sure you block out at least 45 mins as we’re going to dive really deep into your current biggest regulatory challenge and its solution.
In this one-to-one private and completely confidential Accelerated Regulatory Action Call, we will work with you and resolve your biggest regulatory challenge.
Looking forward to speaking with you and finding Rapid Regulatory Solutions.
If it feels like we’re a good match for each other and we can help you get long-term consistent results, then we’ll let you know how we can help you further.